Covid-19 Update

Lord Kakkar Excerpts

Monday 21st September 2020 Lords Chamber

[Lord Bethell (Con)]

My Lords, the noble Baroness raises an important point about the rollout in the devolved Administrations. I do not have the details in my brief but I would be glad to write to her with them.

[Lord Kakkar (CB)]

My Lords, I draw the House’s attention to my registered interests. The Minister has alluded to the strategy, announced by Her Majesty’s Government earlier this month, of moving to mass population testing for citizens, regardless of symptoms. This is clearly predicated on having capacity for high-frequency testing, rapid reporting of results and a minimum threshold of accuracy for the test used. What assessment have the Government made of the threshold of accuracy in relation to sensitivity and specificity required to ensure that the mass testing strategy is successful—which is essential if we are to not only implement public health measures but save our economy?

[Lord Bethell (Con)]

My Lords, the user cases for different tests are being drafted and interrogated as we speak. The user case, for example, of an anaesthetist going into a delicate operation would be very different from the asymptomatic testing of a large school, or of people thinking about going to the pub in the evening. Matching the tests with the user cases is an important and necessary step. Once that is agreed with all relevant scientific committees, we will publish those user cases so that manufacturers can make the tests according to the required dimensions and specifications.

Covid-19: Rise of Positive Tests

Lord Kakkar Excerpts

Wednesday 9th September 2020 Lords Chamber

[Lord Bethell (Con)]

Testing arrangements for care homes have, as the noble Baroness, Lady Jolly, alluded to, risen dramatically. Testing is done in a large variety of ways. For large care homes, mobile testing facilities are put in place; for care staff, facilities at local NHS hospitals are in place; and we invite visitors to have tests in advance of visiting their loved ones. This is all overseen by the NHS Test and Trace programme, and the CQC remains the auditor of the care sector.

[Lord Kakkar (CB) [V]]

My Lords, I draw noble Lords’ attention to my registered interests, in particular my membership of your Lordships’ Science and Technology Committee. In his appearance before that committee in July, the Government’s Chief Scientific Adviser suggested that the higher the number of cases in circulation at the beginning of winter, the greater the likelihood of a significant peak of disease. What assessment have Her Majesty’s Government made of scientific evidence on the threshold at which the number of new cases might suggest that we can no longer be confident that the NHS will have sufficient capacity to deliver both its routine winter service and manage resurgent Covid-19 admissions?

[Lord Bethell (Con)]

My Lords, we are well within the threshold that the noble Lord, Lord Kakkar, alludes to, but we are concerned about winter. That is why we are putting in place new restrictions and new arrangements to stop the spread of this disease, protect the NHS and save lives.

Medicines and Medical Devices Bill

Lord Kakkar Excerpts

2nd reading & 2nd reading (Hansard) & 2nd reading (Hansard): House of Lords
Wednesday 2nd September 2020 Lords Chamber

[Lord Kakkar (CB)]

My Lords, I thank the Minister for introducing this Bill. In so doing, I remind noble Lords of my registered interests, particularly as professor of surgery at University College London and chairman of UCLPartners.

The Bill is important, as has been emphasised on so many occasions during this debate, because at its heart its purpose is to secure patient safety. Beyond that, it has the objective of ensuring a regulatory environment in which our life sciences industry can thrive. That is important because, beyond financial services, the life sciences are the second-largest contributor to our economy. However, patient safety comes first.

A number of issues in the Bill should have enjoyed detailed debate at Second Reading, but the way we are forced to conduct Second Readings at this time and the limited time we have to explore these issues make that impossible. However, I will identify and bring to your Lordships’ attention two specific issues that will need to be explored in Committee.

The first is the question of clinical trials. Twice in your Lordships’ House, Her Majesty’s Government have given very clear assurances that the clinical trials regulation that will at some point be adopted and implemented in the European Union would have its provisions reflected in UK legislation. It is regrettable that the new clinical trials regulation will not be in place by the time we leave the European Union and therefore not automatically become part of EU retained law.

The important issue here is that the trials regulation replaces the current clinical trials directive, which is defective. It seems unfortunate and unacceptable that, having lobbied so strongly in Europe to replace the current directive with the new regulation, our country, our patients and our researchers will be left with the defective current directive on the statute book. Why do Her Majesty’s Government not wish to use the current opportunity of this Bill to undertake implementation of the key improving provisions of the clinical trials regulation so that our research community and patients can benefit from an enhanced and much more effective clinical trials regulatory environment as we move forward?

The second issue is regulation of medical devices. We have heard much discussion about this problem during this debate. It is quite right that Clause 16 of the amended Bill, having completed its passage in the other place, provides for the opportunity to create registries to look at marketed device products to ensure that they can be traced and patients identified, but it does not deal with the important question of what level of evidence for the safety and efficacy of a device should be necessary before marketing authorisation is provided in the United Kingdom. This is vital.

There are trial methodologies beyond clinical, randomised trials which could be instituted that provide the opportunity for limited authorisation of new devices with patients included in prospective registries with very careful follow-up. The comparison of data from those patients with broader patients with similar diseases and conditions would allow for a proper safety evaluation of newly marketed devices and, ultimately, broader marketing once those initial data were made available. That would be the appropriate approach to patient safety. I hope Her Majesty’s Government will consider using the Bill to provide that kind of certainty.

Independent Medicines and Medical Devices Safety Review

Lord Kakkar Excerpts

Wednesday 15th July 2020 Lords Chamber

[Lord Bethell]

I thank the noble Lord for his searching questions. The role of the MHRA on both medical devices and medicines has been massively upgraded, and the review process for new medical devices has been improved. However, medical devices have different criteria from medicines.

One of the most important things that we have sought to do is to include a registry of the medical devices themselves and a registry of the medical devices inserted into individuals. Compliance with both procedures are the most important steps for clinicians embarking on new products.

[Lord Kakkar (CB) [V]]

My Lords, I thank the Minister for answering questions on this Statement and in so doing remind noble Lords of my registered interests. In her excellent report, the noble Baroness, Lady Cumberlege, identifies concerns about the lack of evidence that is required prior to the granting of marketing authorisation for many medical devices, where all that is often required is demonstration of equivalence to an already marketed product. The noble Baroness highlights the striking difference that exists with regard to the situation for medicinal products, where robust evidence of efficacy and safety is required before a medicinal product can be marketed. Are Her Majesty’s Government content with this situation—this difference between the level of evidence required before a product and a device can be marketed as regards patient safety? If there are concerns, what approach do Her Majesty’s Government propose to take with regard to ensuring that there is proper evidence of both the safety and efficacy of a device prior to its broad marketing and use in large populations of patients?

[Lord Bethell]

The noble Lord alludes to an extremely difficult balance that we have to seek to make. He is entirely right that medical devices and medicines operate on different criteria. The most important thing is that the MHRA resources for focusing on the approval of medical devices have been improved and the procedures enhanced. However, medical devices remain an important area of potential innovation, and we are concerned not to suffocate this area of potential improvement as it has been suffocated in other areas. At present, the Government believe that we have struck the right balance, but we remain keenly focused on it and it is under constant review.

Contraceptives and Hormone Replacement Therapy Drugs

Lord Kakkar Excerpts

Wednesday 18th March 2020 Lords Chamber

[Lord Bethell]

The noble Baroness is entirely right to express her frustration. It is enormously frustrating for those concerned and for our medicine supplies. Medicine production is a long-term business. There was a point when HRT consumption went down, but then demand grew exactly when some production facilities had backed off their supply. It was an incredibly unfortunate combination of events that has led to this situation, but I reassure the House that we are working extremely hard to provide alternatives and to replace those most favoured products that are in short supply at the moment.

[Lord Kakkar (CB)]

My Lords, I remind noble Lords of my declared interests. Has thought been given to whether novel therapies that might soon become available from research elsewhere in the world might be applied to the management of patients infected with coronavirus in our own country? Is the Minister content that the current regulations that govern the use of medicinal products in man are sufficiently flexible to allow for drugs that not only currently exist but might be repurposed for this, and for novel and innovative therapies, neither of which might be licensed for use in the United Kingdom at the current time, to be made available without further impediment if that was thought to be a useful intervention?

[Lord Bethell]

The noble Lord, Lord Kakkar, is entirely right to stress this point about regulation. I assure him and the House that we are working extremely closely with Public Health England and the MHRA to ensure that there will be no regulatory hurdle that prevents the swift introduction of proven, safe products into the UK market. This is a massive priority that has had great scrutiny from both the department and Downing Street. It is one that we are focused on and will continue to focus on.

Coronavirus

Lord Kakkar Excerpts

Monday 9th March 2020 Lords Chamber

[Lord Bethell]

The noble Baroness is absolutely right about the importance of guidance and I reassure her that an enormous amount of work is being done to draft clear guidance for employers, volunteer groups and all parts of society, which will include case studies, FAQs and detailed recommendations. That work is being guided by the CMO and senior officials at PHE.

As for 111, we look very closely at the metrics for the return of calls. Overall, the headline figures suggest that the 111 service is bearing up incredibly well under intense pressure, but I do not deny that there must be people who have had bad experiences. These pressures sometimes lead to poor results and we will keep a very careful eye on that.

[Lord Kakkar (CB)]

My Lords, I declare my registered interests. Clearly, the decision to move from the phase of containment to that of delay is essential to sustaining the ability of the health delivery system to deal with this problem.

What objective criteria will be used to determine how that decision is taken? How are the behaviour and natural history of this disease elsewhere in the world being used to inform when we should move from containment to delay?

[Lord Bethell]

The noble Lord asks an important question. The truth is that it is more of an art than a science. Efforts were made to look at clear metrics for triggering this result, but it is a complex situation and our understanding continues to develop. It is ultimately up to the judgment of the CMO and the confidence of the Secretary of State to make that call.

Queen’s Speech

Lord Kakkar Excerpts

Thursday 9th January 2020 Lords Chamber

[Lord Kakkar (CB)]

My Lords, I thank the Minister for the very thoughtful way in which she introduced this broadly based debate. She was able to reaffirm Her Majesty’s Government’s commitment to public services—none more than our National Health Service. She also demonstrated the very important government commitment to the area of science and innovation. In so doing, I remind noble Lords of my own registered interests, and in particular a new registration as chairman of the King’s Fund.

The issue of the provision of healthcare is critical to every citizen in our country. Not only is the provision of healthcare vital in terms of protecting our fellow citizens; it is critically important in ensuring that we have a healthy population who are able to contribute to the economy, and of course in ensuring that the vital investment that is made in the National Health Service and in the broader ecosystem that surrounds our National Health Service can be used to drive an important element of our economy: life sciences.

In the gracious Speech, Her Majesty’s Government outlined a number of important commitments to strengthen the provision of healthcare in our country in this coming Parliament, including: the area of the workforce, in terms of enhanced training, and the capacity to attract trained professionals from overseas to work and support our NHS through the provision of a new visa scheme; ensuring and enhancing patient safety through the introduction of a new investigatory mechanism, which needs to be thoughtfully introduced so as not to cut across the important regulators and the multiple mechanisms for investigation that already exist when there has been a mishap in the delivery of healthcare and where lessons need to be learned; and the commitment to enshrine in law the additional funding that is critically required to deliver the sustainability of our NHS.

I turn to two other important issues highlighted in the gracious Speech. The first is the capacity for integrated care, which will be critical if the additional funding provided is to be used in an appropriate way that will have a meaningful impact. Integrated care is of course the integration of primary with specialist care, the integration of care for physical and mental health, and the integration across the health and social care boundaries.

Her Majesty’s Government have received from NHS bodies some suggestions on legislative change that may be required to ensure that they can mobilise themselves effectively to deliver this important integrated care agenda. When do the Government propose to respond to suggestions that NHS England and NHS Improvement be merged, and that providers and commissioners of healthcare at a local level may form joint decision committees able to ensure a better integration of care, rather than having to have major legislative change to create new statutory bodies? It is critically important that, ahead of determining how this additional investment in the health service is to be spent, the structures in which the money will be applied are properly defined and the Government are absolutely content that they are fit for purpose to deliver the important objectives necessary for the long-term sustainability of the NHS.

It is also critically important to be clear that the voluntary joint decision-making committees, between commissioners and providers at local level, will be of sufficient authority to drive the changes in the delivery of care and working practices, and the construction of care environments, that will be necessary to ensure the successful application of this additional funding.

I turn finally to the question of innovation. Once again, Her Majesty’s Government, through the high-risk science fund—of which life sciences might represent an important component—seeks to demonstrate a broader commitment to the life sciences sector in our economy. The publication of the industrial strategy recognises the important contribution life sciences make to our economy—£74 billion per annum—and the 250,000 of our fellow citizens who are employed in the life sciences industry, to such great effect.

An important question remains about how that industry will interact in undertaking clinical research. The Government are committed to ensuring that our life sciences and healthcare economy become the most advanced and innovative in clinical research and the evaluation of innovation. How do the Government propose to do that in the context of still being able to participate effectively in the new clinical trials regulations that will exist for the rest of the health economy in Europe?

Queen’s Speech

Lord Kakkar Excerpts

Tuesday 22nd October 2019 Lords Chamber

[Lord Kakkar (CB)]

My Lords, I thank the Minister for introducing this debate and reminding your Lordships of the elements of the Queen’s Speech relating to healthcare provision and the science sector in our country. I remind noble Lords of my interests as professor of surgery at University College London and chairman of UCLPartners. It is a pleasure to follow the noble Baroness, Lady Walmsley.

I would like to pick up on some points made by my noble friend Lord Patel. I reiterate the tremendous regard and respect that all Members of this House, and I in particular, have for my noble friend Lady Emerton. She has made a remarkable contribution to your Lordships’ House and is one of its kindest and most thoughtful Members. It has been a great pleasure and privilege to come to know her since I was fortunate enough to join the House.

The Queen’s Speech rightly identified Her Majesty’s Government’s commitment to healthcare and the NHS. Clearly, safety is vital and the Government should be congratulated on introducing legislation to establish the health service safety investigations body. However, there are a number of potential concerns. A number of other organisations in the broad structure for the delivery of healthcare and other regulators already have a safety responsibility—NHS trusts, professional regulators, the Care Quality Commission, NHS Improvement and so on. All these bodies have statutory responsibilities. How will Her Majesty’s Government ensure that there is not regulatory overreach, which can have a detrimental effect on openness and transparency and impede the objective of ensuring that safety is at the heart of healthcare delivery? It is a very important question. Further regulation without consideration of what is already available could be very harmful.

There is also a clear commitment to ensuring that the additional funding already identified for the provision of healthcare in the NHS is appropriately applied. In this regard, are Her Majesty’s Government satisfied that the current landscape and the disposition of NHS England and NHS Improvement are appropriate, or do they present something of an impediment to the establishment of proper integrated care? This must ensure that the community base, rather than hospitals, is the focus for the management of chronic diseases, and that we have a system that facilitates the appropriate management of patients with established disease and ensures that prevention is at the heart of our ongoing healthcare strategy.

The adoption of innovation is also absolutely critical. The landscape, populated by many bodies, is particularly defined by the academic health science centres and health science networks. Are Her Majesty’s Government content that that structure is appropriate to facilitating the adoption of innovation at pace and scale, or is it necessary to look at those particular designations, and indeed other elements of the system, to ensure that they are better co-ordinated to deliver the adoption of innovation? Innovation will be critical to the sustainability of our NHS; we need innovation not only in novel therapies, medical devices and technologies but in how we develop the workforce to respond to the challenges of the next two decades.

We are also particularly privileged in our country to have a unique ecosystem defined by the National Health Service, our universities—we have four of the top 10 in the world for biosciences and life sciences—a remarkable pharma industry sector and, of course, a biotech and medtech sector. Those sectors commercially provide some £63.5 billion of turnover to the UK economy, employ more than 200,000 people and represent some 5,000 companies. That is of huge importance, not only for ensuring that innovation is established quickly, discovered and brought to bear to manage the diseases of our fellow citizens, but for its economic contribution. This has been well recognised by recent Governments, who have shown important commitments to this area.

However, in a report published in September, the Institute for Public Policy Research identified that whereas in 2011 our country enjoyed 10.5% of global spending on life sciences R&D, that figure fell to just 7% in 2016, despite an important commitment by the Government. The circumstances around Brexit have caused further uncertainty in the life sciences sector. It is a matter of deep regret that there might be further delay in delivering Brexit.

The implications of this are substantial for this important part of our economy, but they are also vital because if we fail to sustain the pace of innovation in life sciences, we will not deliver an NHS that can provide the most important benefits for our fellow citizens. That NHS will not be able to contribute to the growth of the economy and to increased wealth creation in our country because patients and individuals will be less healthy and less economically productive, and the broader benefits of this important sector will be lost to our country.

Academic Health Science Centres

Lord Kakkar Excerpts

Tuesday 2nd July 2019 Grand Committee

[Lord Kakkar (CB)]

My Lords, I also thank my noble friend Lord Butler of Brockwell for introducing this debate so thoughtfully. I declare my interest as chairman of University College London Partners, one of the designated AHSCs, and professor of surgery at University College London. As we have heard from the noble Lord, AHSCs were first designated some 10 years ago, following the review by the noble Lord, Lord Darzi of Denham, at the 60th anniversary of the NHS. Their clear purpose was to overcome the two translational gaps: the one between a discovery and establishing a therapy in man, and the one between that and ensuring it can be used more broadly across a relevant population. As we have also heard, there has been huge success in achieving the two objectives of overcoming translational gaps 1 and 2 with great effect on outcomes for individual patients, performance in broad health economies and opportunities for wealth creation in our country. It should be borne in mind that the life sciences represent, after financial services, the second most important part of our economy.

The nature and complexity of innovation and the broader questions attending health systems have changed over that 10-year period. We are faced with demographic change and important fiscal challenge and restraint in health economies. It is broadly accepted that the adoption of innovation is critical if health economies are to remain sustainable. Organisations such as academic health science centres therefore have a pivotal role. As we have heard, successive Governments have recognised not only the potential role of these centres, but the broader question of innovation in health economies through the creation of other designations, such as AHSNs, collaborations for applied research, biomedical research centres and so on. As we come to this third designation for academic health science centres, the question for Her Majesty’s Government is: what specific purpose do they see for AHSCs in the changed landscape for innovation in our health economies? Where do the AHSCs sit in terms of these other structures and designations, how are they to be co-ordinated, and how will we determine their success? We also have to try to understand whether the designation of academic health science centres in the future will be attended by contractual obligations, as we saw recently in the redesignation of the academic health science networks. To date, each of the AHSCs has been able to perform effectively, but driving its own agenda determined by its own local priorities and regional, national and global opportunities. Will that be the case in the future?

There remains also an outstanding question about how government and arm’s-length bodies in the NHS propose to facilitate the most important opportunity for academic health science centres: that is, their capacity to mobilise data across complex health economies and bring those to bear, not only on drug discovery but on changing the patterns and application of clinical care, development of the workforce, and of course the utilisation of vital resource most effectively. Do Her Majesty’s Government propose to deal with this particular question of mobilising the opportunity for health informatics in redesignation of academic health science centres? Finally, as we have heard, these designations come without any funding. Is it proposed that, at the time of redesignation, some funding is provided to the AHSCs?

Lung Health

Lord Kakkar Excerpts

Monday 1st July 2019 Lords Chamber

[Baroness Blackwood of North Oxford]

The right reverend Prelate raises an extremely important point on air health. While we have long-term commitments in the clean air strategy, and the other measures that have been put forward in the Green Paper and net-zero commitments, NICE has published guidance on the effect of air pollution on people with chronic respiratory and cardiovascular conditions. We also have the Committee on the Medical Effects of Air Pollutants, which advises the Government on many matters, including those the right reverend Prelate raised.

[Lord Kakkar (CB)]

My Lords, I remind noble Lords of my registered interests. Are Her Majesty’s Government satisfied that the research strategy between UKRI and the National Institute for Health Research is sufficiently well co-ordinated to ensure discovery, as well as early evaluation and adoption, of novel therapies that could manage chronic lung disease more effectively?

[Baroness Blackwood of North Oxford]

The noble Lord has raised a crucial point, which is not a surprise given his expertise in this area. We have been working with him and others to ensure that the most innovative medicines are getting to patients as quickly as possible. We announced the Accelerated Access Collaborative to identify those innovative medicines and ensure that we speed up the rate of ideation to uptake in the NHS, particularly for illnesses such as asthma. For example, smart inhalers and integrated connected devices could dramatically improve the management of that condition.